bottle of 10 mg ambien pills

Back in 2013, the United States Food and Drug Administration (FDA) announced that the recommended Ambien dosage for women should be halved.

That meant many women who were used to a dosage of 10 mg might only be prescribed 5 mg in the future.

But was that unfair to female insomniacs? Or is it justified considering the alleged increase in the risk of driving accidents in the morning?

To answer these questions, some background to the issue is needed.

The new dosage

The FDA announced that it had told manufacturers of sleeping pills containing Zolpidem, such as Ambien, that they should reduce the recommended dosage.

So the standard Ambien dosage for women was reduced from 10 mg to 5 mg. And for extended release formulations, it was reduced from 12.5 mg to 6.25 mg.

For men, however, the FDA only recommended that doctors consider lowering the dosage to 5 mg and 6.25 mg respectively.

In addition, the FDA added that medical practitioners should advise patients that they are at a higher risk of impaired mental alertness.

Clinical trials showing worse driving skills

The reason behind the change is recent clinical trials and driving simulation studies. They found that some women perform certain tasks, such as driving, less well the morning after taking Ambien.

They found that women eliminate Zolpidem slower than men, though men also have a small chance of driving worse the next morning.

This was widely reported in the news, but what’s particularly interesting is the reaction from many people who rely on such sleeping pills to manage their insomnia.

How high is the risk really?

The comments sections of online news articles show a strong reaction from people who believe that they tolerate their higher Ambien dosage well.

Many people feel they pose no potential threat to others from activities such as driving – especially those that don’t even drive.

Unsurprisingly, the manufacturers of Ambien, Sanofi, also released a statement saying that they believe Ambien to be safe. This is according to their clinical data and 20 years of use by millions of people.

Ambien has indeed had a great deal of testing by people. It’s the most popular sleeping pill available in many countries.

In 2011 in the United States alone, 44.8 million prescriptions were written for sleeping pills containing Zolpidem.

With so much apparently safe usage of the higher Ambien dosage, how bad could the results of these simulation studies have been?

Too much Ambien in the bloodstream the next morning

photo of a woman driving

The driving simulation studies found that if people have over 50 ng/mL Zolpidem in the blood, there’s an increased risk of having a driving accident.

The simulation studies involved 250 men and 250 women taking a dose of 10mg Ambien.

8 hours after dosage, they discovered that 15% of women and 3% of men exceeded the levels of 50 ng/mL. And 4 people had more than 90 ng/mL.

And those who took the extended-release 12.5mg had even higher incidents of elevated Zolpidem amounts in the blood: 33% of women and 25% of men.

Zolpidem-related driving accidents

Interestingly, the FDA says on their website that they have “about 700 reports of zolpidem and impaired driving ability and/or road traffic accident.”

They also say that it was only when they received the data from the driving simulation studies that they took action to reduce the dosage; up until then, it was difficult to work out what role the sleep aid really had in those 700 incidents.

So it seems that the combination of the two pieces of information was key to the decision making, not just the simulation studies.

What the manufacturer of Ambien says

ambien 10mg pill bottle

This issue isn’t new news, with the following statement appearing on Sanofi’s website:

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem

They then go on to say:

Due to the risk to the patient and the community, discontinuation of Ambien CR should be strongly considered for patients who report a “sleep-driving” episode.

So should people be given a chance to continue with the old Ambien dosage and drive responsibly? Or should a potentially life-threatening risk be prevented outright?

Another statement on Sanofi’s website raises another point to consider:

As with “sleep-driving”, patients usually do not remember these events.

So if patients don’t always remember that they were sleep-driving, how can they be expected to report the episode?

Why insomniacs feel it’s unfair

There appear to be several reasons some people feel the change is unfair:

  • They feel they shouldn’t be punished because the drug can have dangerous effects on a minority of people.
  • The dosage should be tailored to each individual’s needs.
  • They believe some people don’t follow the guidance properly – timing, mixing with alcohol etc.
  • If they don’t get a good night’s sleep, they are even more at risk of having a driving accident.
  • Some people don’t drive anyway, so why should the rule apply to them?

While the frustration of people who Ambien helps sleep is understandable, the risks have to be balanced.

Although the FDA states that only a few dozen incidents of sleep-driving have been reported, they suspect there are many more unreported cases.

Update to the FDA guidance

ambien pills

When this news first broke in 2013, it provoked disappointment and outrage because of the sudden and strict dosage change.

I’ve kept an eye on the guidance over the years, and noticed that it has changed more than once. There was a change at one point to suggest the dosage could be increased again if the lower dosage wasn’t effective.

More recently in 2018, the exact wording on the FDA website has again changed to suggest a more tailored approach based on the individual instead.

Here are some excerpts from the guidance that I think are interesting:

FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses. These lower doses of zolpidem (5 mg for immediate-release products and 6.25 mg for extended-release products) will be effective in most women and many men.

And here is what the advise for people already on a higher dosage:

If you are currently taking the 10 mg or 12.5 mg dose of zolpidem-containing insomnia medicine, continue taking your prescribed dose as directed until you have contacted your health care professional to ask for instructions on how to safely continue to take your medicine. Each patient and situation is unique, and the appropriate dose should be discussed with your health care professional.

They also have this to say concerning the argument about weight and other factors having a role to play:

Based on data from pharmacokinetic trials, no relationship was evident between the zolpidem blood level and patients’ body weight or ethnicity.

If you’d like to keep up to date with any changes to the recommended dosage, you can do so by looking at the website linked above, and also section on Ambien dosage at drugs.com.

Your view

Do you find Ambien affects your ability to drive in the morning? Do you feel it was an unfair change in dosage?

Please leave a comment below with your thoughts.

119 thoughts on “Why The Ambien Dosage For Women Is Lower”

  1. You know what’s really dangerous? Driving to work after only three hours of sleep. You know what’s bad for your heart? Sleep deprivation. Guess what can make you depressed? Not getting enough sleep. Shall I go on?

    I have taken Ambien for several years, with a few breaks. I have not had a single car accident in that time. Nor have I sleepwalked, sleep-eaten, or had any negative side effects.

  2. Like others, Ambien is the only sleep aid that has worked for me. I have tried literally everything else and I will not list them. I resent like h**l being told that if I just though it out I will be able to sleep. Nope. Anyhow, I did taper off my 10 mgs of Ambien to 5 (my idea as it did make me groggy in the morning) and then, trying to get to zero, to 2.5. I just break the 5 mg pill in half. Much to my surprise, it works. I take my bp meds and Neurontin at bedtime and those put me to sleep. Then when I inevitably wake up at 3-4 I take my 2.5 mgs of Ambien and wake up again at 7:30. So my nitwit doc has decided she no longer wants to prescribe Ambien for anyone. I am beyond POd. I did a reasonable taper down to the least amount of this med that will help e. I am in no way impaired when I get up, and I do not have to take more to get the same effect. I am an insomniac and this drug helps me. It is unconscionable that docs will not help. Sorry for the venting.

  3. I will be 69 in about a week. I have taken Zolpidem for nearly 3 decades. I have never been a day person. I was even home schooled because of this issue. Now people do not see doctors. All doctoring is done by a PA or nurse. They are not allowed to assess you as an individual for your particular needs. The FDA and corporations lump everyone as if we are all the same person. This is based on less than 1% of the population. Most testing is simulated which does not prove actual viable information. The individual has no say or control over their own medical care. This is the way of the future for medical care. Hopefully people in the right position will lobby to give us a right to vote for our right to help in managing our own medical care with real Doctors.

  4. I’ve been taking 10 mg Ambien/Zolpidem over 20 years for insomnia. Discovered when I tried to wean/stop that I just couldn’t function or sleep. The pharmacist said I’m likely physically dependent — stopping causes rebound insomnia. But it doesn’t work as well as it used to. I also have fibromyalgia and a few other issues, so lack of restful sleep leads to long stretches of pain (weeks, months). So now also taking 25 mg amitriptyline, which has made a tremendous difference. (Also getting up 2 hours later than my usual 10 hours in bed). When I was hospitalized in 2015, they would only give me 5 mg, didn’t say why. I was still awake at 4:30 a.m. and having a bit of a breakdown about it. I’m female, but perhaps obesity has allowed docs to continue prescribing 10 mg.

  5. I have been taking 10 mg of ambien for 13 years with no side effects.
    I am 73 years old. Now my doctor will only prescribe 30 tablets every two months. My doctor said I should try and take them every other night or try other sleep aids that don’t work. Lack of sleep I don’t have any energy. I need my SLEEP!

  6. Hi, Have any of you tried ordering Ambien online? Which site? I’m about ready to order online since my new Dr (took over practice from my retiring long-time Dr) thinks I can’t take the dose I’ve been getting for close to ten years. Lack of sleep is causing more migraines and irritability. Thanks!!!

  7. Anonymous says:
    It is amazing how physicians with advanced psychiatric training are unwilling to practice their chosen profession-medicine- and be the decision makers in the health of their part. Yes, they may actually have to “perform” and take the time to add their names to a needless list for the FDA.
    The consequences for myself continue to surface but thank goodness I have found a neurologist who wants to treat my migraines and realizes that I need to get restful sleep. By the way I have been on Ambien for approximately 10 years with no adverse reactions.
    Sorry I had to change psychiatrists and am working to rid myself of any and all psychotropic medications so I don’t have the need for the “skills” of a psychiatrist.
    I will hopefully continue with Ambien so I may sleep and “drive safely.”
    0

  8. I have taken 10mg of ambien for over 15 years. I have had no strange episodes. Only take when I’m in bed. I am over 65 a women and now for over a year dr will not prescribe. Have tried multiple sleep aides none work like ambien. Of course its unfair. We are not all the same. Some can tolerate it well. I don’t drink alcohol or do any other drugs. I could get drunk legally take a ton of benadryl but can’t take 10mg of ambien because I might fall?

  9. I have Post Traumatic Stress Disorder from serving in the military. I am on many different medications, and Ambien is a life saver for me. Yes, I have migraines and other medical conditions, but all of these are worsened if I cannot sleep, and I just don’t sleep well or sometimes at all without Ambien. I have not had any episodes of sleep walking or sleep driving while on this medication. I am blessed to have a doctor at the Veteran’s clinic who understands this.

  10. I went to the doctor today and was told no more ambien for me because I am over 65. I have never had any side effects and have taken 1/2 a pill for the past 8 years. This is discrimination and the FDA should be sued. I am going to find a new doctor. I work full time and just because I am 66, I am being punished because of a small minority of people who has experienced side effects. It is going to keep me from getting a decent night’s sleep. I am extremely angry about this situation.

  11. Didn’t realize that I am
    It alone and how MANY people need this medication…. with NONE of the widely publicized..possible.. side effects ….. Ambien is the ONLy medication that has Ever helped me sleep … without druggy / nasty side effects…. it is so depressing to me that you can get Many sorts of mind altering .. so called.. Anti- Depressants….. YET …. I can only get a smaller than effective dose of Ambien because I am a woman. I take No Other medication…. tried Klonopin but to no use….. Need to sleep to be able , at 66 years old , to continue to earn a living…..Thanks for venue to whine… however…. what can be done to help ???

  12. I need my sleep!!! It helps keep the migraines down. I have been on zolpideim for some years now different mgs 10, 6.5cr , 12.5cr due to the 10 not working as long within 2 to 4 hrs I would be up, yes up not sleep walking not sleep talking!! Wide up. Well I’m back on 6.5cr. ?. I’ve noticed if I get the correct amount of sleep the migraines are some what lessened for the month. I don’t care what you giving a man over a woman is it really helping the individual?

  13. I have been using this for insomnia for 18 +/- years. I have NO SIDE EFFECTS what so ever. I get a good nights sleep and no drugged hangover, either. Now I have to try different drugs and none have done a thing except make me sick and deprive me of much needed rest. I believe patient and Doctor should be the ones to decide which drug works the best for the patient. I couldn’t tolerate REPATHA after 8 months or so. My body just pitched and awful fit of side effects. I had to start taking a drug for nephropathy, while on that stuff. I hope the idiots that made this decision for me will get syphilis and rot out their ignorant brains! POd ROYALLY

  14. I am a 75 YO female. My Dr. has taken me off Ambien. (Zolpidem). I have been taking AS NEEDED for 20 +/- YEARS! I am so extremely PO’d. I have a rare type of system, where a huge number of medicines will not work with me or will have serious side effects. (i.e.) Cholesterol meds worked several years then would start causing sever side effects. Then REPATHA came out. WOW these injections did awesome for about 8 months, more or less, Then boom! that last injection nearly put me in hospital. I HAD to quit it. Anti-depressants are always way too strong. I HAVE to cut them all by 1/2. This list goes on. My Dr. slipped and said, “You’re weird.” Then, quickly, ” No, no I meant unique. All my patients are unique.” I can’t do a thing about the way my system is made. Today he prescribed me DOXEPIN HCL 10mg. I have never heard of that, but I will do look up on it, before I try it tonight. It cost me nearly $17.00 for 30 capsules. Lunesta was $47.00 another was $37.00 Zolpidem was less than $6.00. Somebody seems to be working on getting Seniors to PAY a hell of a lot more for our NEEDS. Really makes me wish I could control THEM, instead of this way round. GRRRRRRR.

  15. Margaret Morrison

    I have fibromyalgia and sleep apnea as well as chronic low back pain.
    My doctor just cut my Ambien to 5mg. I am not sleeping as well and I am actually more tired. I have called my doctor’s office on two separate occasions to let my doctor know the problem I am having. She has not verbally responded
    and continues to only give me the 5 mg.dose. I am honestly disappointed and exhausted. I have been on this dosage since 1983 and have tried other sleep meds
    which leave me exhausted as well. I hope they see this is not fair to the patients who are suffering the same as me.

  16. For 18 years I’ve taken Ambien without major problem. EXCEPT WHEN: taken with alcoholol,tranquilizers, similar meds like muscle relaxers.
    One med that doesn’t bother me is tizabidine. So far. I think it may be tightining, rather than relaxing muscles, so I may have to quit it

  17. I was prescribed ambien 10mg over 15 years ago because I have fibromyalgia. Now they want me to take 5mg!! What’s wrong is one of the Kennedys had a wreck and blamed it on ambien and ruined it for those who need it. I don’t abuse it but need it. If I can’t sleep during the night I have to lay around in bed or on the couch all day the next day. Wouldn’t it be better if I could sleep and perform the next day. My dr gave me trazadone and I felt like my heart was beating out of my chest and was up until 4am. This is ridiculous. Not a happy camper.

  18. Moved to another state. I have been a patient of my regular PCP for 30 yrs. I had my first appointment with another doctor to see if he will be my new PCP. Within a 10 min exam, he decides I should take Ambien 5 mg instead of 10. I have been happy and well maintained with the 10 mg dosage. I take Lorazepam twice a day…as needed. The doctor recorded that I take Lorazepam at the same time as the Ambien. Over trial and error, I was finally managed with Ambien 10 mg. But I am a woman so I get a lower dose? Pissed

  19. I think the dosage is unfair for women like me who take ambien 5mg a night. It allows me to go to sleep about an hour after taking it. It last for 3 and a half hours and I’m up and wide awake the rest of the night. Then im exhausted all day…I think that’s a bad thing don’t you…I mean being exhausted and having to function on 3 and a half hours of sleep every night. And my Dr only gives me 20 tablets to last for 30 days…seriously ?!!
    So I have 10 days without meds…so i have to pick which nights not to sleep at all….good idea !! NOT

    1. You are taking an opiate as a long term sleep aid, which will make it even harder for you to sleep. Wean yourself off the drug. Your doctor should know better. Getting off Ambien and establishing healthy sleep habits will not be easy but it is doable.

      1. Richard Pendleton

        Sorry Omar, Ambien is not an opiate.
        To those who don’t have insomnia it’s always just get off the drug. Are there any tests that show that everyone is able to get off Ambien or is that wishful thinking?

  20. Hi guys I found your website thru a google search. I am 40 years, I am currently mentally disabled.
    I have been taking 10mg of Ambien for 7 years. I have been suffering with chronic insomnia for the last 10 years. After I started taking Ambien 7 years ago, it was amazing when I started it. It would put me asleep within 30 minutes. I would sleep good 8 hours and wake up my alarm at 6:30 to go to work. No doziness or side effect like the OTC insomnia pills caused.
    I took Ambien until 2015, when i asked my doctor to switch me, I was given Seroquel 200mg to sleep, it works but the weight gain was horrible. After 1.5 years taking Seroquel, I requested to be taking off. I was prescribed Trazodone 100mg , it did not work. Talked to my doctor and he put me back on Ambien 10mg January 2018. I was dealing with grief of losing my Mom, Nov 2017. Ambien 10mg was not working. So I started taking 1mg of Xanax with the Ambien to help me sleep. It worked , but I was running out of my anxiety pill before my refills. I had nothing for my anxiety. I went to the Dr. In July 2018, I asked him to prescribe me something to help get me asleep because Ambien wasn’t working alone . He prescribed Trazadone 100mg to be taken with the Ambien 10mg . I no longer need to use my anxiety medicine to help put me asleep. Problem is I am completely knocked out for 12 hours Every night. I am unable to wake up. I am not liking this. What would you recommend and is this normal with this dosage 10mg of Ambien and 100 mg of Trazadone?

    Thanks, sorry for being long winded.

    1. Hi there
      Thanks for your comment. Sorry to hear you’ve been having trouble with the medication and side effects. I can’t really advise you on what you should or shouldn’t do. But I would say that it’s a good idea to talk to your doctor again about not being able to wake up. Perhaps they can try you on a lower dosage.
      Regards
      Ethan

  21. Hi Ethan, I think Ambien/Zolpidem is a wonderful drug if used sparingly & cautiously. I don’t believe it should be used every night but if someone’s insomnia is pretty bad then 3x a week should be sufficient and they should not develop a tolerance/addiction to them – which can happen with all drugs that alter GABA levels in the brain if taken every day or night.

    Not a lot of people know this but it should also be noted that Alcohol, Benzos and Z drugs like Zolpidem & Zopiclone all alter and increase GABA levels in the brain which reduces anxiety and initiates sleep and a “cross tolerance” can develop. So if someone has been drinking alcohol on it’s own to sleep then stop and take a Benzo or a Z drug the night after drinking alcohol they won’t work as good at all especially if the sedative effects to alcohol has built up – the brain cannot distinguish the difference because all those drugs and alcohol influence GABA. The brain needs a break from alcohol and the others so the sedation works better.

    1. Hi Gareth
      Thanks for your comment. You’re right in that drugs like these can make a big difference to some people’s lives where nothing else helps them sleep. The trick is to use them carefully and effectively. And generally, the more substances you take that affect the brain, the more of a chance of them altering the effectiveness of each other.
      Regards
      Ethan

  22. I’m female and just turned 65. Now that my doctor won’t prescribe the 12.5 dosage, I am going to have to go ahead and retire before I want to. Since my profession is as a tractor trailer driver I CANNOT go days without sleep and safely drive a big truck. I always allowed myself 10-12 hours off duty time before driving. Ambien is the only sleep aid that has worked for me.

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